Minimally-invasive Non-surgical Treatment in Teeth With Unfavourable Prognosis

NCT04236648 | Unknown

• 1 other identifier: Perio-19-001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a pilot prospective cohort study to assess the efficacy of minimally-invasive non-surgical periodontal therapy (MINST) for the treatment of teeth with unfavourable periodontal prognosis. 20 patients who have teeth with unfavourable periodontal prognosis (due to bone loss to the apex or furcation involvement grade II C) will receive minimally-invasive non-surgical treatment (MINST) and will be reassessed up to 12 months after treatment.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

• Radiographic defect depth

  defect depth measured in radiographs in mm (as measured on standardised radiographs)

  baseline-12 months

• Furcation involvement

  furcation involvement measured clinically (as measured based on validated horizontal and vertical furcation involvement scales, by Hamp et al. 1975 and Tarnow 1984). Hamp et al. 1975 goes from 1 to 3 in increasing severity. Tarnow et al. score goes from A to C in increasing severity

  baseline-12 months

Secondary Outcomes (5)

• probing pocket depth

  0-12 months

• clinical attachment level

  0-12 months

• patient-reported outcomes

  0-12 months

• inflammatory response (in saliva and GCF)

  0-12 months

• subgingival microbes

  0-12 months

Study Arms (1)

Minimally-invasive non-surgical therapy (MINST)

OTHER

Study treatment

Procedure: Minimally-invasive non-surgical therapy (MINST)

Interventions

Minimally-invasive non-surgical therapy (MINST) PROCEDURE

subgingival root debridement with a minimally-invasive approach using piezoelectric/ultrasonic instruments

Minimally-invasive non-surgical therapy (MINST)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
• Presence of:
• N=10: Maxillary or mandibular molars with:
• A. Furcation involvement degree II C based on Hamp et al. 1975 horizontal classification and Tarnow \& Fletcher 1984 vertical classification (with concomitant furcation involvement (FI) not exceeding degree II on the other aspects of the same tooth) B. gingival recession ≤ 2mm on furcation site C. mobility maximum degree 2
• N=10: 'Teeth with bone loss to the apex' (also defined as 'hopeless' by Cortellini et al. 2011), defined as having:
• A. radiographic bone loss to the apex or beyond the apex on at least one inter-dental aspect B. presence of severe attachment loss (\>10 mm) at the same inter-proximal site/s and at least at one of either the buccal or lingual aspect (Cortellini et al. 2011) C. lack of function because of hypermobility, and/or lack of chewing strength, and/or pain, and/or recurrent periodontal infection/abscesses (Cortellini et al. 2011) D. positive response to vitality testing with electric pulp test (EPT) or previous endodontic treatment considered satisfactory, as judged by the examining clinician
• \- Willing to sign informed consent to take part in the study

You may not qualify if:

• Smoking (any current or in past 5 years)
• Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable disease
• History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
• Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
• Systemic antibiotic therapy during the 3 months preceding the baseline exam
• History of alcohol or drug abuse, vii) Self-reported pregnancy or lactation
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
• Periodontal treatment to the study site within the last 12 months

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Luigi Nibali, PhD

CONTACT

02071887188; luigi.nibali@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 22, 2020
• Study Start: February 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2023
• Last Updated: January 22, 2020

Record last verified: 2020-01